Digital Agile CSA | What does GAMP 5 Second Edition say?

gamp5-second-edition

Meeting date: July 24, 2023, 12: 30 PM ET

Many organizations want to move faster and adopt an agile methodology for delivery of IT projects, but struggle with how to do so with validated systems. On the surface, agile seems to be opposed to the concept of validation and the implied need to create, review, and approve many deliverables. Using GAMP 5 Second Edition and supplemental materials, we will look at how to successfully transform from waterfall into a truly agile delivery method including validation.

  • We’ll discuss common roadblocks to implementing agile and validation overall.
  • Gain an understanding of how ALM tools can be used to ensure compliance and speed to delivery.

Speakers:

🎤 Stephen J. Cook : VP – Validation Quality & Compliance at Compliance Group Inc.

🎤 Jonathan Meuzelaar : Director, Technology Solutions at Compliance Group Inc